This invention relates generally to incontinence devices, and, in particular, to a fecal incontinence device wherein a gas- or liquid-fillable bag is used as an applicator.
There are many medical and veterinary situations where a biological substance, such as blood, urine, feces, serum, etc. is drained and collected from the body of a patient as the substance is being produced. For example, it is known to attach devices such as colostomy bags and fecal incontinence devices to natural or surgically created orifices of the patient""s body for collection of the feces which is produced. See, for example, my U.S. Pat. No. 4,850,986 and patents referenced therein, for a description of a fecal incontinence device.
Typical substance collection bags make it possible for a patient to stay clean and dry even when the patient is comatose or otherwise indisposed. Applying articles of this type may be difficult, however, particularly if the patient is overweight, incapacitated, or both. It often requires two individuals to apply these devices, one to move the patient, and the other to actually install the appliance. Although applicators are available for this purpose, they tend to be separate items which must be dealt with on an independent basis, including disposal. In addition, although modern incontinence devices include an adhesive which is thermally activated, care-giving personnel often do not take sufficient time to activate this adhesive sufficiently, resulting in a failed seal and the need for reapplication. The need remains, therefore, for an integral applicator for use with such devices, and one wherein, ideally, a warm liquid could be used to activate the adhesive, where possible.
The present invention improves upon existing incontinence devices and like appliances, which currently utilize separate, rigid applicator elements, by providing a fillable bag which, when filled, assumes a manually graspable form suitable for use as an applicator.
With respect to a fecal incontinence device, the invention preferably provides a thin-walled, elongated waste-receiving bag and the same or a separate fillable bag which is temporarily filled with a gas such as air or a liquid or such as water. The resulting structure is sufficiently rigid that a care-giver may grasp the device and urge the opening of the waste-receiving bag against a recipient, after which the bag used as an applicator may be emptied. One advantage of using a gas or liquid as opposed to a solid structure is that the gas or liquid more readily conforms to a particular recipient""s anatomy.
The invention contemplates at least three preferred embodiments, wherein the fillable bag is adjacent the waste-receiving bag, within the waste-receiving bag, or wherein closure means are provided enabling the waste-receiving bag itself to function temporarily as the fillable bag. In all embodiments, should the end of the waste-receiving bag include a thermally activated adhesive to improve the integrity of contact to a recipient, the fillable bag may be filled with warm water or other liquid to provide the additional function of activating the adhesive.
According to the embodiment of the invention wherein the fillable bag is adjacent the waste-receiving bag, both bags preferably include capped drainage ports, enabling the fillable bag to be filled and emptied after application, and enabling the waste-receiving bag to be drained periodically once adhered. Although the fillable bag according to this embodiment attaches on one side of the waste-receiving bag, when the waste-receiving bag is deflated and the fillable bag is filled, grasping of the device causes the end of the fillable bag toward the recipient to be urged into intimate contact with the adhesive area, thereby permitting thermal activation.
According to a second embodiment of the invention, the fillable bag is disposed substantially within the waste-receiving bag, in which case the drainage port of the waste-receiving bag is utilized to fill and empty the fillable bag contained therein. Filling of the internal bag may conveniently be carried out with an gas- or liquid-filled syringe, and the fillable bag includes separate closure means to ensure that it remains filled during application of the device.
According to a third embodiment of the invention, the waste-receiving bag and fillable bag are one in the same. To ensure that the contents of the fillable bag are not expelled during application, the recipient-receiving end of the structure is blocked with an internal seal, preferably including a pull string that extends through the bag and out the drainage end. Use of the invention according to this embodiment includes the process of filling the bag with a gas or liquid and having the recipient-receiving end blocked off, and with the pull string extending through the bag and out the drainage end, but captured through the plug at the drainage end. Following application, the drainage end is opened, and the string is pulled, causing the seal to become disengaged and detached from the waste-receiving end, enabling it to be pulled through the drainage port or left in the waste-receiving bag, with the port then recapped for use.
In further alternative embodiments of the invention, chemicals may be provided to initiate one or more reactions to generate heat to activate the adhesive and/or to produce a gas to fill the form. In addition, particularly where the fillable bag is disposed along side the waste-receiving bag, the fillable bag may be provided to the care-giver as a separate component and used on an as-needed basis.